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Allied Labs

This article was originally published in The Tan Sheet

Executive Summary

Minneapolis-based OTC drug manufacturer corrects cGMP problems cited in a Nov. 2 FDA warning letter. Violations included "failure to calibrate instruments...at suitable intervals" and "failure of...laboratory records to include complete data derived from all tests necessary to assure compliance with established specifications." In a Nov. 23 correspondence, FDA notes the firm's "responses appear to adequately address the observations...listed in the warning letter." Goldberg Consulting, which acquired Allied Labs in July, said major changes are being implemented at the Allied facilities. The firm contract manufactures items such as dentifrices and mouthrinses

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